Judge lifts limit on contraceptive

A federal judge on Friday ordered that the most common morning-after pill be made available over the counter for all ages, instead of requiring a prescription for girls 16 and younger. But his acidly worded decision raises a broader question about whether a Cabinet secretary can decide on a drug's availability for reasons other than its safety and effectiveness.

Gail and Chris Randall, parents of Harison Long-Randall, leave the courtroom Friday during a break in the preliminary hearing of Paul William Walden in Sacramento Superior Court. Walden is accused in the July hit-and-run crash in Carmichael that killed Long-Randall.
lsterling@sacbee.com

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By Pam Belluck - The New York Times

A federal judge on Friday ordered that the most common morning-after pill be made available over the counter for all ages, instead of requiring a prescription for girls 16 and younger. But his acidly worded decision raises a broader question about whether a Cabinet secretary can decide on a drug's availability for reasons other than its safety and effectiveness.

In his ruling, Judge Edward R. Korman of the Eastern District of New York accused the Obama administration of putting politics ahead of science. He concluded that the administration had not made its decisions based on scientific guidelines, and that its refusal to lift restrictions on access to the pill was "arbitrary, capricious and unreasonable."

He said that when the health and human services secretary, Kathleen Sebelius, countermanded a 2011 Food and Drug Administration move to make the pill – which helps prevent pregnancy after sexual intercourse – universally available, "the secretary's action was politically motivated, scientifically unjustified, and contrary to agency precedent."

Sebelius said at the time that she was basing her decision on science because she said the manufacturer had failed to study whether the drug was safe for girls as young as 11, about 10 percent of whom are physically able to bear children. But her decision was widely interpreted as political because emergency contraception had become an issue in the abortion debate and allowing freer access for adolescents would prompt critics to accuse the president of supporting sexual activity for young girls.

At the time, President Barack Obama was campaigning for re-election, and some Democrats said he was conscious of avoiding divisive issues that might alienate voters. He said then that he was not involved in the decision but supported it. "As the father of two daughters, I think it is important for us to make sure that we apply some common sense to various rules when it comes to over-the-counter medicine," he said.

And he reiterated that position Friday through the White House press secretary, Jay Carney, who said, "He believed it was a common-sense approach when it comes to Plan B and its availability." Carney declined to comment on whether the administration would appeal the decision.

Korman gave the FDA 30 days to lift age and sale restrictions on the pill, Plan B One-Step, and its generic versions.

Many groups in Obama's political base praised the decision to make the emergency contraceptive pill more easily available, a position that in some ways is more consistent with the administration's position on other reproductive health issues, including the free provision of contraceptives through the health care overhaul.

Scientists, including those at the Food and Drug Administration, have recommended unrestricted access for years, as have the American Medical Association, the American Congress of Obstetricians and Gynecologists and the American Academy of Pediatrics. They contend that the restrictions effectively keep many adolescents and younger teenagers from being able to use a safe drug in a timely way to prevent pregnancy, which carries greater safety risks than the morning-after pill.

Conservative and anti-abortion groups assailed the judge's decision, suggesting that it may allow the pill to be given to young girls without their consent. They also say that girls who can skip the requirement to visit a doctor for a prescription may have sexually transmitted infections that go undiagnosed and untreated.

The judge's decision, a rare case in which a court has weighed in to order that a drug be made available over the counter, could test the question of who gets the final say in such matters.

"Technically the secretary under the law has the right to make the decision," said Daniel Carpenter, a professor of government at Harvard. "But there is other long-established law that says the decision is supposed to be based on the safety and efficacy of the drug."

The drug's manufacturer, Teva Pharmaceuticals, declined to comment on the decision Friday. In a separate order, the judge denied a motion by the company to preserve market exclusivity.

Plan B was approved in 1999 as a prescription-only product, and in 2001, the Center for Reproductive Rights filed a citizens petition for it to be made available over the counter or without a prescription.

Scientists, including an expert advisory panel to the FDA, gave early support to that request. But top agency officials rejected the application because, some said later, they worried they would be fired if they approved it.

President George W. Bush's administration in 2006 allowed over-the-counter sales to women 18 and older but required a prescription for those 17 and younger. In 2009, Korman directed that the pill be made available over the counter for those 17 and older.

A former Health and Human Services official during Obama's first term said that when Sebelius overruled the FDA in 2011, she was concerned about the lack of research about how the drug would affect very young girls. But the official, who declined to be named, said the secretary was also being pragmatic by not taking a stand that would have drawn intense criticism from foes of abortion.

MORNING-AFTER PILL AT A GLANCE

WHAT IT IS: The morning-after pill is the common name for a class of drugs known as emergency contraceptive pill. Levonorgestrel, which is marketed as Plan B and Next Choice, is the most common form. These pills contain a higher dose of the female progestin hormone than regular birth control drugs.

HOW IT IS USED: If taken properly and in time, usually within 72 hours of unprotected sex, it reduces the chance of pregnancy by up to 89 percent. According to the Centers for Disease Control and Prevention, one in nine sexually active women have used it, and 41 percent of them have used it more than once.

WHAT IT ISN'T: The morning-after pill is not everyday contraception nor is it the same as the so-called abortion pill, RU-486, which is also legal in the U.S. Morning-after pills work by preventing fertilization of an egg and have no effect on pregnant women.

WHAT WAS DECIDED: A U.S. district judge in New York ruled that the 2011 age restrictions set by Health and Human Services Secretary Kathleen Sebelius on over-the-counter sales of the morning-after pill are arbitrary and must end within 30 days. A Justice Department spokeswoman said it would be "reviewing the appellate options."

WHAT IT MEANS: Women of any age can buy emergency contraception over the counter instead of requiring a prescription for girls 16 and younger.